Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumours of the Lung

Official Title

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumours

Summary:

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Trial Description

Primary Outcome:

  • Incidence of device or procedure related complications
Secondary Outcome:
  • Rate of device or procedure related complications
  • Rate of all pneumothoraxes
  • Total procedure time
  • Rate of conversion to conventional bronchoscopic procedure
  • Rate of adverse events unrelated to device or procedure
  • Stage at diagnosis
  • Diagnostic yield
  • Sensitivity for malignancy
  • Rate of post-bronchoscopy infections

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society